A Randomized Clinical Two-arm Trial Comparing Inflammation and Cystoid Macular Edema for the Medication Regimens Postoperative Topical NSAIDs and Steroids to Only Postoperative Topical Steroids in Patients Undergoing Corneal Endothelial Transplantations (DMEC)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Central macular thickness after 4 weeks
研究概览
简要总结
The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
- •Scheduled for DSAEK or DMEK
- •Ability to cooperate fairly well during the examinations
- •Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.
排除标准
- •Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
- •Pregnancy or possible pregnancy during the study period
- •Preoperative macular edema and/or ongoing treatment for macular edema
- •Re-transplantation
- •In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
- •Aphakic eyes (eyes without a biological or artificial intraocular lens)
- •Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
研究组 & 干预措施
Control (dexamethasone only)
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
干预措施: Dexamethasone Ophthalmic (Drug)
Study group (NSAIDs and dexamethasone)
Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.
干预措施: Nepafenac Ophthalmic (Drug)
Study group (NSAIDs and dexamethasone)
Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.
干预措施: Dexamethasone Ophthalmic (Drug)
结局指标
主要结局
Central macular thickness after 4 weeks
时间窗: 4 weeks after surgery
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 4 weeks
时间窗: 4 weeks after surgery
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
次要结局
- Intraocular inflammation(Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery)
- Intraocular pressure(Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery)
- Visual outcome(Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery)
- Corneal endothelial status(1 week, 4 weeks, 2 months and 2 years after surgery)
- Patient reported outcome measure (PROM)(1 week, 4 weeks and 2 months after surgery)
- Central macular thickness (CMT)(Preoperatively, and 1 week, 2 months, and 2 years after surgery)
- Cystoid macular edema (CME)(Preoperatively, and 1 week, 2 months, and 2 years after surgery)
研究者
Olav Kristianslund
Principal investigator, Senior consultant MD PhD
Oslo University Hospital